CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8 enrolled
Drug / intervention
UGN-102drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05136898
NCT05136898Phase 3Completed
CompareCT.gov

A Phase 3b, Open-Label, Single-Arm, Multicenter Study to Assess the Feasibility of Home Instillation of UGN-102 for Treatment of Patients With Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) at Intermediate-Risk (IR) of Recurrence

UroGen Pharma Ltd.·interventional·Posted Nov 30, 2021·Updated Sep 19, 2024

In Brief

A Phase 3 clinical trial evaluating UGN-102 for Bladder Cancer and 2 related conditions. Completed, enrolled 8 participants across 5 sites.

Detailed Summary

This study aims to demonstrate that home instillation of UGN-102 is a feasible alternative to instillation in a clinical setting, which might mitigate patient challenges (logistical, expense, and comfort) when receiving treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedNov 30, 2021
Enrollment StartNov 30, 2021
Primary CompletionFeb 2, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.6 years ago

Interventions

UGN-102drug

UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.